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Clinical Research Management

Location:
WB, 713102, India
Salary:
as per norms
Posted:
February 08, 2016

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Resume:

CRA-RESUME

KAUSHAL SHINDE

RSA*/**b,

Renaissance township,

Nawabhat more,

Nh2, behind mother diary plant,

Burdwan-713102.

West bengal .

actft4@r.postjobfree.com

Contact No. -082******** (presently)

Contact No: +91-943*******

( Willing to relocate)

Career Objective

I am also looking forward to opportunities of growth both on intellectual and professional level.

To be associated with Progressive Organization that gives scope to apply my knowledge and skills in areas of Development and Application to take part in the team that dynamically works towards the Growth of the Organization.

Projects

1)To compare the Pharmaco-vigilance systems in European Union, USA and India and to study the effect of Pharmaco-vigilance system in India.

2)To design sponsor’s protocol as an assignment for PH-II trial.

3)To design the CRF (Case report form) with compatible ICD(Informed consent document).

Performed 35 site selection for oncology and other protocols, and I have 6 years exp. For core monitoring clinical trials .

1)Gastronox study for ph-III open level, multi-centric, for inoperable gastro-esophageal cancer.

2)LEP-ETU, breast cancer study for ph-II

3)Locally advanced Squamous cell-carcinoma for head and neck, ph-IV study for Post

Marketing Survey .

4) Study of taxotere in indian patients. ph-iv study for post marketing survey.

5) (BE study) A double blind randomized controlled trial in pre- school age children to evaluate the impact of a nutritional beverage powder on cognitive performance measures.

6)(BE study) Deramatology study for acne vulgaris for CMBP drug (clindamycin benzylperoxide)

7) (BE study) Opthalmalogy study for ocular instillation after cataract surgery for Lotepredenol gel and solution.

8) (BE Study) Urology study for urological infection for pentosan drug.

Experience

Working with lotus labs, as Senior Officer- Clinical Development. From july1st 2014 till date.

Worked with Inventiv health clinical cro as a Clinical research associate-II june 2013 to june 2014 in bangalore.

Worked as CLINICAL RESEARCH ASSOCIATE from august 2008 to may 2013 and monitored the Oncology Projects for Bengal Oncology Research, Kolkata, West Bengal.

Worked as CLINICAL RESEARCH ASSISTANT june 2007 to july 2008 in PH-III study for malaria. At pulse diagnostic clinic pune.

Responsibilities:

1) Regular monitoring and coordination with site personal.

2) Conducting Site Initiation Visit, Investigator team interaction/meeting in the site.

3) Clinical trial document maintenance (Source data verification, ICD review, SAE reporting, Drug accountability).

5) Ensure the maintenance of Investigator site file. (ISF)

6) Ensure CRAs Coordination with central lab and source document amendments.

7) Mentoring sites and CRAs during trial monitoring visits.

9) Site interaction with staff during site visit.

10) Ensure with CRAs Adverse event reporting with SAE.

11) Ensure Compensation agreement maintenance with time line management for recruitment of subjects.

12) Report to Principal Investigator and Senior Clinical Operations Manager.

13) Ensure delivery of study drug consignment records maintenance.

14) Coaching trial protocol at site initiation. Training CRAs for pre-site initiation.

15) Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects

16) Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;

17) Liaising with doctors/consultants (or investigators) on conducting the trial;

18) Training site staff to industry standards

19) Ensuring that data tracking on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)

20) Discussing results with a medical statistician, who usually writes technical trial reports

21) Archiving study documentation and correspondence.

22) Ensure the preparing Final clarification with site personnel after tracking the DCF (data clarification forms and MCF (monitor clarification forms) at trail site visits.

23) Site Identification and finalization of Clinical Trial Agreement with the Sponsor.

24) Finalizing budget and payment schedule.

25) Maintaining Line management.

26) Sponsor meeting on weekly basis.

Total Exp: 8 years

Proficiency

Type

Knowledge

Clinical Research

ICH Guidelines, Regulatory Affairs, Pharmacovigilance, Site Management, Data Management, Biostatistics

E-CRF module software training

Training done on Info 4.0 and 4.5 phase forward for data capturing and discrepancy management in this e-crf module.

Experience in Oracle Clinical- RDC (Raw Data Capture).

Professional Skills

*** Post Graduate Degree in Clinical Research(ICH-GCP Guidelines) with Clinical data management from, Bio Informatics centre, University of pune.

Academic Details

Qualification

Year of Passing

Board/University

Institute

PG Course in Clinical Research & Clinical Data Management

August 2007

University of Pune, India

Bioinformatics Center, Pune University

M.Sc. (plant biotech)

July 2004

Pt. Ravi shankar shukla University,Raipur- (C.G.), India

Govt. College of science, Raipur-(C.G.), India

B.Sc. (Industrial Microbiology)

June 2002

Pt. Ravi shankar shukla University,Raipur- (C.G.), India

Govt. College of science, Raipur-(C.G.), India

H.S.S.C. 12 th

April 1998

M.P.BOARD, India

National Convent High school, Raipur.(C.G.).

India

S.S.C 10th

May 1996

Bihar board, patna

Shivaji high school, benogaria, dhanbad.

Personal Details

Name kaushal Shinde

Date of Birth 20th December, 1982

Father’s Name Mr. S.K.Shinde

Languages Marathi,English, Hindi, ***Bengali. (all languages able to read and write.



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